{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T01:32:51Z","timestamp":1770255171604,"version":"3.49.0"},"reference-count":19,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T00:00:00Z","timestamp":1757548800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T00:00:00Z","timestamp":1757548800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    This study assessed the pharmacokinetics (PK) and bioequivalence (BE) of valsartan and amlodipine (80\/5\u00a0mg) tablets in healthy Chinese subjects under fasting and fed conditions. A randomized, open\u2010label, four\u2010period crossover trial was conducted, with participants receiving test (T) or reference (R) formulations in cycles separated by a 14\u2010day washout. Plasma concentrations of valsartan and amlodipine were measured using high\u2010performance liquid chromatography\u2010tandem mass spectrometry. PK parameters were analyzed noncompartmentally, and BE was evaluated using reference\u2010scaled average bioequivalence (RSABE) for high\u2010variability parameters (CV\n                    <jats:sub>W<\/jats:sub>\n                    \u2265 30%) and average bioequivalence (ABE) for low\u2010variability parameters (CV\n                    <jats:sub>W<\/jats:sub>\n                    &lt; 30%). Under fasting conditions, the maximum concentration of drug in blood plasma (C\n                    <jats:sub>max<\/jats:sub>\n                    ) of valsartan was assessed using RSABE methodology and demonstrated bioequivalence. For amlodipine, bioequivalence was established through conventional ABE analysis, with the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    all residing within the predefined equivalence boundaries. Under postprandial conditions, both drugs met BE criteria using ABE, with 90% CIs of GMRs within the acceptable range. Importantly, postprandial administration resulted in a significant reduction of approximately 30% in systemic exposure of valsartan for both test and reference formulations. All adverse events were mild and transient. The T and R formulations demonstrated bioequivalence and were well tolerated, supporting their interchangeability.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1597","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T06:43:29Z","timestamp":1757659409000},"page":"911-917","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence of Two Formulations of Valsartan and Amlodipine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"14","author":[{"given":"Yu\u2010Ying","family":"Xu","sequence":"first","affiliation":[{"name":"Department of Pharmacy Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen\u2010Tan","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei\u2010Ping","family":"Pan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xie\u2010Li","family":"Guo","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian Campus)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao\u2010Min","family":"Li","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center, Xiangya Hospital, Central South University  Changsha Hunan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Su\u2010Mei","family":"Xu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center, Xiangya Hospital, Central South University  Changsha Hunan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shao\u2010Wei","family":"Yan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen\u2010Ke","family":"Cai","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin\u2010Bin","family":"Yan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Jinjiang Municipal Hospital (Shanghai Sixth People's Hospital Fujian)  Quanzhou Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen\u2010Jing","family":"Zhong","sequence":"additional","affiliation":[{"name":"Research and Development Department, Chengdu Brilliant Pharmaceutical Co., Ltd.  Chengdu Sichuan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shi\u2010Lin","family":"Chen","sequence":"additional","affiliation":[{"name":"Analysis and Testing Department, Chengdu Finelyse Pharmaceutical Technology Co., Ltd.  Chengdu Sichuan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ping\u2010Sheng","family":"Xu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center, Xiangya Hospital, Central South University  Changsha Hunan China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,9,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms241612911"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.122.321762"},{"issue":"2","key":"e_1_2_10_4_1","first-page":"237","article-title":"Hypertension and heart failure: prevention, targets, and treatment","volume":"40","author":"Di Palo KE","year":"2022","journal-title":"Cardiol Clin"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.121.023397"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41371-022-00776-9"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2021.09.026"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.24082"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph19074156"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1155\/2022\/5054511"},{"issue":"2","key":"e_1_2_10_11_1","first-page":"773","article-title":"Efficacy and safety of single pill combination of amlodipine and valsartan in hypertensive Saudi patients","volume":"27","author":"Alluhabi SI","year":"2023","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hipert.2023.11.004"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2023.1110459"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-022-06504-5"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/jch.14709"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.727"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S253078"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12249-024-02835-5"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S485851"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S423374"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1597","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1597","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1597","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T12:37:48Z","timestamp":1769863068000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1597"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,11]]},"references-count":19,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/cpdd.1597"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1597","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,11]]},"assertion":[{"value":"2025-03-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}